To the Editor
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I have recently seen a cluster of patients with late complications of the Raindrop corneal inlay.
By way of history, the Raindrop corneal inlay was initially approved for sale in the United States on June 29, 2016. On Oct. 23, 2018, an FDA Safety Communication was issued for the Raindrop corneal inlay. ReVision Optics ceased commercial operations Jan. 30, 2018. My estimate of the number of Raindrop corneal inlays implanted during the period of commercial implantation is between 2,000 and 3,000.
The primary reason for the FDA communication was the development of corneal haze, which could reduce clear vision. However, I have observed other significant issues associated with untreated corneal haze, which include impending corneal melt, corneal melt and corneal melt with extrusion of the inlay.
I was an FDA investigator in the original clinical trial and have now removed all of the nearly 40 inlays I implanted in the FDA trial. The most concerning patients seen recently presented with impending corneal melts. An effort was made by the company and implanting surgeons to contact every patient implanted with the Raindrop to notify them of the FDA communication and offer them treatment options ranging from inlay explantation to more frequent and regular follow-up examinations. Despite this effort, some patients have not responded to the notifications, and some have chosen to continue with the inlay despite the known associated risks.
There was a “honeymoon” period noted in the FDA trial in which patients and surgeons reported good outcomes, and this “honeymoon” period was extended during the commercial implantation period by placing the inlay deeper in the cornea and using mitomycin C to delay the development of corneal haze. In my experience, this “honeymoon” period of good outcomes is about a year and a half after implantation.
I recommend that every surgeon who implanted a Raindrop corneal inlay advise their implanted patients of the need for careful follow-up. I have also observed corneal haze develop up to 6 months after explantation of the device. While the exact magnitude of the problem is unknown, I want to alert my colleagues regarding my observations.
Harvey L. Carter, MD
Carter Eye Center, Dallas
- Reference:
- Increased risk of corneal haze associated with the Raindrop near vision inlay: FDA safety communication. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm. Published Oct. 23, 2018. Accessed Sept. 29, 2020.
The Editor responds:
Even those ophthalmologists, like me, who never implanted a ReVision Optics Raindrop near vision inlay may see patients like the ones Dr. Harvey Carter has described in his timely letter to the editor.
If a patient presents with reduced vision, irregular topography/tomography and interface haze, the corneal inlay should be removed. If the surgeon is uncomfortable performing this procedure, I would recommend referral to an experienced colleague, usually a corneal fellowship-trained refractive corneal surgeon. Excess topical steroids are not effective in reversing this problem and can result in secondary glaucoma, so do not overtreat with steroids.
Once the inlay is removed, the patient’s vision will be reduced, topography/tomography will reveal irregular astigmatism, and interface haze will be observed at the slit lamp. Much like in patients with severe stage 4 diffuse lamellar keratitis, there may be corneal thinning and loss of corneal tissue in the interface. The best treatment is “tincture of time” and artificial tears. Nearly all patients will show slow improvement up to 5 years, with corneal remodeling, progressive reduction in irregular astigmatism, and improved uncorrected and best corrected visual acuity. While healing, the patient can be fit with a contact lens, usually a gas permeable hard or scleral contact lens. Patients can be counseled that they will slowly improve, although there may be some permanent loss of vision, and they may require contact lens wear for best vision. Those who persist with significant vision loss can be treated with lamellar keratoplasty.
The ophthalmologist who removes a corneal inlay should return it to the manufacturer, in this case, Optics Medical. The cases should also be reported on MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Further details as to corneal inlay management following removal and reporting requirements can be found online by searching Raindrop corneal inlay recall.
Richard L. Lindstrom, MD
OSN Chief Medical Editor
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